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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Safety Assessment of Monoglyceryl Monoesters as Used in Cosmetics
Author:
Monice M. Fiume, Bart A. Heldreth
Year:
2015
Bibliographic source:
Cosmetic Ingredient Review, December 14-15, 2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal irritation potential of Glycerol esters of rosin in rabbits
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Resin acids and Rosin acids, esters with glycerol
EC Number:
232-482-5
EC Name:
Resin acids and Rosin acids, esters with glycerol
Cas Number:
8050-31-5
IUPAC Name:
Glycerol esters of rosin
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):Glyceryl Rosinate
- IUPAC name: Resin acids and Rosin acids esters with glycerol
- Substance type:Organic
- Physical state:Solid
- Purity:No data available
- Impurities (identity and concentrations):No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report):Glyceryl Rosinate
- IUPAC name: Resin acids and Rosin acids esters with glycerol, Glycerol esters of rosin
- Substance type:Organic
- Physical state:Solid
- Purity:No data available
- Impurities (identity and concentrations):No data available

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data available

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
semi-occlusive patch applied to intact skin; 0.5 g applied
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema or edema was observed

Any other information on results incl. tables

 

Table: Results of the primary irritation study – dermal

Name of the test chemical

Concentration/ dose

Number of animals/ group

Procedure

Results

Glyceryl rosinate

No vehicle, but moistened with water, 0.5g

3 New Zealand White rabbits

4h semi occlusive patch, intact skin, 0.5 g applied to skin, animals were observed up to 72 hours

No erythema and no edema.

Not irritating

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No erythema or edema was observed in the rabbits during the 72 hour observation period.
Glycerol esters of rosin was considered to be not irritating to rabbit skin.
Executive summary:

The irritant effects on rabbit skin, was assessed for glyceryl rosinate. 3 New Zealand White Rabbits were subjected to a 4-h semi-occlusive patch test. 0.5 g test chemical was applied to intact skin, no vehicle was used but test chemical was moistened with distilled water. Animals were observed for up to 72 h

No erythema or edema was observed in the rabbits during the 72 hour observation period.

Glycerol esters of rosin was considered to be not irritating to rabbit skin.

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